News
FDA extends PDUFA date for review of baricitinib for the treatment of atopic dermatitis. - Eli Lilly + Incyte
Eli Lilly and Company and Incyte have announced that the FDA has extended the review period for the supplemental New Drug Application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD).
The FDA extended the action date to allow time to review additional data analyses submitted by Lilly in response to recent information requests from the FDA. The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021.
Condition: Atopic Dermatitis (Eczema)
Type: drug
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